Senior QC Manager - Pharma Quality & Compliance

ALK-Abello, Inc; Plainville (CT); On-site; USD 110,000 - 125,000; Full time

Benefits offered by this job

Excellent benefits including medical,d

Job summary

ALK-Abello, Inc. in Plainville, CT is seeking a skilled Quality Control Manager to lead daily QC operations in Chemistry and Microbiology labs, ensuring cGMP compliance and accurate testing across environmental monitoring, water testing, stability, and release processes.

The successful candidate will manage QC staffing, budgeting, and documentation, train staff, drive continuous improvement, and serve as the subject matter expert during audits by FDA, Health Canada, and other bodies.

Qualifications

• BS / BA in life sciences, biology, chemistry or related field preferred.
• This position requires minimum 5 years of progressive management experience in a laboratory setting with increasing responsibilities in Pharmaceutical or GMP environment.
• Knowledge of current Good Manufacturing Practices (cGMP), USP, FDA and ICH guidelines is required.

Responsibilities

• Oversee daily QC operations in Chemistry and Microbiology laboratories, ensuring end-to-end compliance of incoming, in-process and routine operations and testing including environmental monitoring, water testing, stability, production, and incoming material release.
• Collaborate with other departments to resolve quality-related matters.
• Author, edit, review, and approve documents, including SOPs, work instructions, deviations, CAPAs, change controls, protocols, and environmental monitoring reports.
• Responsible for QC (Microbiology and Chemistry) administration, scheduling, and budgeting.
• Ensure compliance with regulatory standards and industry best practices (GxP).
• Oversee and adhere to global quality metric goals and plant metrics.
• Requisition and procurement of laboratory supplies related to QC laboratories and production support.
• Provide ILT (Instructor-Led Training) to QC team members on laboratory documents, including SOPs, WINs, and protocols - ensuring all staff are properly trained and qualified for assigned tasks.
• Provide support, leadership, and development of QC team members.
• Oversee plan and execution of product validation and stability studies, ensuring accurate data verification, reporting, and compliance with regulatory requirements.
• Ensure calibration, maintenance and operation of lab instrumentation, including balances, pH meter, UV/vis spectrophotometer, and other analytical equipment as necessary.
• Serve as primary subject matter expert during internal and external audits (e.g. FDA, Health Canada, Notified Body, and supplier audits).
• Foster a culture of quality and continuous improvement within the team and other departments.
• Other duties as assigned.

Skills

Quality control management

GxP compliance

Laboratory leadership

Regulatory knowledge

Education

BS / BA in life sciences

Job description

ALK-Abello, Inc. in Plainville, CT is seeking a skilled Quality Control Manager to lead daily QC operations in Chemistry and Microbiology labs, ensuring cGMP compliance and accurate testing across environmental monitoring, water testing, stability, and release processes.

The successful candidate will manage QC staffing, budgeting, and documentation, train staff, drive continuous improvement, and serve as the subject matter expert during audits by FDA, Health Canada, and other bodies.